At a Glance

Why Get Tested?

To determine the level of the drug tacrolimus in your blood in order to establish a dosing regimen, maintain therapeutic levels, and detect toxic levels

When to Get Tested?

As soon as tacrolimus therapy begins, frequently at first, then at regular intervals to monitor concentrations over time

Sample Required?

A blood sample drawn from a vein in your arm

Test Preparation Needed?

The sample should be collected 12 hours after your last dose and immediately prior to your next dose or as directed by your health practitioner.

The Test Sample

What is being tested?

Tacrolimus is an immunosuppressive drug that is given orally or intravenously to people who have had a kidney, liver, heart, or other organ transplant. It is a potent drug that helps to prevent rejection of the transplanted organ by the body. This test measures the amount of tacrolimus in the blood.

Normally, a person's immune system recognizes a new, transplanted organ as foreign and begin to attack it. Tacrolimus limits this response and helps to prevent organ rejection by inhibiting the activation of certain immune cells called T-lymphocytes.

The level of tacrolimus in the blood must be maintained within a narrow therapeutic range. If the concentration is too low, organ rejection may occur; if it is too high, then the person may experience symptoms associated with toxicity.

Dosages must be tailored to the individual. Often, people will begin with higher doses of tacrolimus at the start of therapy and then decrease the dose over the next few weeks.

Tacrolimus is usually taken twice a day at set intervals before or after meals. When a person takes a dose, the blood concentration rises and peaks within about 2 to 3 hours and then begins to slowly drop. The blood test is usually measured as a "trough level," meaning that sample collection is timed for 12 hours post-dose and/or immediately prior to the next dose, when the drug's level in the blood is at its lowest.

How is the sample collected for testing?

A blood sample is obtained by inserting a needle into a vein in the arm.

The Test

How is it used?

The tacrolimus test is used to measure the amount of the drug in the blood to determine whether the concentration has reached a therapeutic level and is below the toxic level. It is important to monitor levels of tacrolimus for several reasons:

There is not a good correlation between the dose of tacrolimus given and the level of drug in the blood.

How individuals absorb and metabolize oral doses of tacrolimus can vary greatly depending on the time of the dose and what, if any, food the person has eaten.

Tacrolimus can cause kidney damage (nephrotoxicity), especially in high doses. Measuring levels in people who have had a kidney transplant may help to distinguish between kidney damage due to rejection (because drug level is low) and kidney damage due to tacrolimus toxicity (drug level is high).

Tacrolimus can increase the risk of developing serious bacterial, viral, fungal, and protozoal infections because it decreases the body's immune response.

When is it ordered?

A tacrolimus test is ordered frequently at the start of therapy, often daily when trying to establish a dosing regimen. Once dosages have been established and shown to be well tolerated, the frequency of tacrolimus testing may be decreased. The test is also performed when dosages are changed and whenever someone has symptoms that suggest side effects, toxicity, or organ rejection.

Signs and symptoms of tacrolimus toxicity vary according to the type of organ transplant and may include:

What does the test result mean?

A concentration that is higher than the established therapeutic range may increase the risk of associated toxicity, including damage to the kidneys and nerves. A concentration that is too low may lead to rejection of the transplanted organ. Side effects may be seen at any dosage but tend to be more severe with a higher tacrolimus level.

The therapeutic range established by a laboratory will depend on both the method used to measure the drug and the type of transplant. Results from different methods are not interchangeable. A health practitioner will usually send samples sent consistently to the same laboratory and will be guided by that laboratory's therapeutic ranges.

Is there anything else I should know?

A variety of drugs can increase or decrease tacrolimus levels in the blood. These include calcium channel blockers, antifungal drugs, macrolide antibiotics (such as erythromycin), protease inhibitors, chloramphenicol, and other immunosuppressants, anticonvulsants, and antimicrobials. Tell your health practitioner about any other medications you take, especially cyclosporine, sirolimus, nelfinavir telaprevir, boceprevir, and amiodarone. Many other prescription drugs, grapefruit juice, and herbal supplements such as St. John's Wort can also interact with tacrolimus.

Topical tacrolimus may be used to treat a variety of skin conditions, such as eczema, that have not responded well to other medications. This topical use of tacrolimus is intended to be local, not systemic, and is not usually monitored.

Tacrolimus increases the risk of developing malignancies such as lymphoma and skin cancer, so sunlight should be avoided when taking this drug. It can also cause new onset diabetes, especially in African Americans and Hispanics so a health practitioner may monitor a person's glucose levels. Tacrolimus may also cause QT prolongation, a condition that affects heart rhythm.

People should not alter their dose or the time that they take their dose without consulting with their health care provider. Tacrolimus should be taken consistently with respect to meals. Food, especially high-fat meals, can significantly reduce the bioavailability (amount of the drug that reaches the circulation) compared with fasting.

Women who are pregnant or planning to become pregnant should talk to their health practitioner about associated risks.

Common Questions

1. How long will I need to be on tacrolimus?

Transplant recpients must take tacrolimus or a different immunosuppressant (or combination of drugs) throughout their life. Talk to your health practitioner about the best choice for your condition. This choice may change over time.

2. Who orders tacrolimus tests?

Tacrolimus will usually be monitored by the transplant team that performed the transplant or by a health practitioner who has specific knowledge of the condition or disease for which the drug is prescribed.

3. Should I tell my other health care providers that I am taking tacrolimus?

Yes, this is important information for them to have, partially because of drug interactions and partially because of the immunosuppressive action of tacrolimus. It can affect your ability to heal, to get vaccinations, and may increase your risk of developing certain cancers (such as skin cancers).

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Elsewhere On The Web

Article Sources

NOTE: This article is based on research that utilizes the sources cited here as well as the collective experience of the Lab Tests Online Editorial Review Board. This article is periodically reviewed by the Editorial Board and may be updated as a result of the review. Any new sources cited will be added to the list and distinguished from the original sources used.

Sources Used in Current Review

Prograf. Rx List. Available online at http://www.rxlist.com/prograf-drug.htm through http://www.rxlist.com. Last reviewed September 23, 2013. Accessed February 26, 2014.

Woo, D. and James, W. (2005 May 24). Topical Tacrolimus: A Review of Its Uses in Dermatology. Medscape from Dermatitis 2005;16(1):6-21 [On-line article]. Available online at http://www.medscape.com/viewarticle/505242 through http://www.medscape.com. Accessed on 6/9/07.

(2001). Therapeutic Drug Monitoring: Is it Important for Newer Immunosuppressive Agents? Medscape from Drug Ther Perspect 17(22):8-12, 2001 [On-line information]. Available online at http://www.medscape.com/viewarticle/414907 through http://www.medscape.com. Accessed on 6/9/07.

Martindale, The Complete Drug Reference (Online information). Available online at http://www.thomsonhc.com/hcs/librarian/PFDefaultActionId/pf.PrintReady through http://www.thomsonhc.com. Accessed August 2007.

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This article was last reviewed on March 12, 2014. | This article was last modified on March 12, 2014.

The review date indicates when the article was last reviewed from beginning to end to ensure that it reflects the most current science. A review may not require any modifications to the article, so the two dates may not always agree.

The modified date indicates that one or more changes were made to the article. Such changes may or may not result from a full review of the article, so the two dates may not always agree.